Powered Prosthesis for Amputation

Overseen By Noah Rubin, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: North Carolina State University

Disqualifiers: Stroke, Heart disease, Ulcers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Lower limb amputees rely on their prosthetic to remain active and lead an independent life. In recent years, measuring residual muscle activity has been used to interpret a user's intent and thereby modulate prosthesis control. However, little knowledge is held on how residual muscle activity differs from non-amputated muscle. The research team will analyze and compare neuromuscular physiology in non-amputee individuals and amputees' non-amputated and residual muscles across functional tasks to better understand how amputees control their muscles. Such information will inform design of modern prosthesis controllers.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for powered prosthesis for amputation?

Research shows that using a prosthesis (artificial limb) after amputation can help people regain mobility and independence, with many returning to a useful life. Early use of a prosthesis is linked to better movement and fewer complications. ^{1 2 3 4 5}

Is the powered prosthesis for amputation generally safe for humans?

Research shows that safety is a key focus when testing and using lower limb prostheses. There are protocols to manage risks like falls and injuries, and communication between healthcare teams and patients is important to ensure safety during rehabilitation. ^{6 7 8 9 10}

How does the powered prosthesis treatment for amputation differ from other treatments?

The powered prosthesis for amputation is unique because it actively mimics the biomechanics of a natural leg, using energy-efficient mechanisms to replicate the functions of the knee, ankle, and toe, unlike traditional passive prostheses that are heavier and less functional. This allows for more natural movement and improved mobility, with the added benefit of a longer battery life and the ability to walk indefinitely on level ground without recharging. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for lower limb amputees who use a prosthetic to stay active and independent. It's also for non-amputee individuals as a comparison group. The study aims to understand muscle control in both groups during various tasks.

Inclusion Criteria

Live in the United States

I can walk over curbs, stairs, and uneven surfaces without help.

Exclusion Criteria

Have any cognitive, visual, or balance impairments that affect the ability to provide informed consent or to follow instructions during the experiments

I have had a stroke.

I have heart disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Muscle Activation While Sitting

Participants practice muscle activation of their ankle muscles while wearing sensors measuring their muscle activity and shape.

3 sessions

3 visits (in-person)

Prosthesis Fitting

Participants undergo socket casting and fitting sessions with a powered prosthesis.

3 sessions

3 visits (in-person)

Functional Tasks

Participants perform functional tasks to practice modulating and controlling muscle activation with both passive and powered prostheses.

10 sessions

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after completing the functional tasks.

4 weeks

Treatment Details

Interventions

• Amputation
• Prosthesis Control

Trial Overview The research focuses on comparing the muscle activity of amputated limbs with that of intact muscles in non-amputees. This will help improve how powered prostheses are controlled based on residual muscle signals.

Participant Groups

Group I: Individuals With Amputation Experimental Treatment 1 Intervention

Tasks with a passive prosthesis Tasks with a powered active prosthesis

Group II: Individuals Without Amputation Active Control 1 Intervention

No Intervention Tested in identical tasks for comparison to Individuals with Amputation

Who Is Running the Clinical Trial?

North Carolina State University

Lead Sponsor

Trials

38

Recruited

50,000+

Findings from Research

In a study of 66 adults with amputations, veterans reported significantly lower levels of posttraumatic growth (PTG) compared to civilians, suggesting that veterans may need targeted support for recovery.

Participants who regularly engaged in support groups experienced significantly higher PTG scores, indicating that support group participation can enhance recovery and personal growth after amputation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Posttraumatic growth in individuals with amputations. Stutts, LA., Stanaland, AW.[2022]

A systematic review identified 64 studies assessing health-related quality of life (HRQL) in patients after amputation due to peripheral artery disease (PAD) or diabetes, highlighting the need for better evaluation tools.

Only one amputation-specific patient-reported outcome measure (PROM) was found suitable for all patients post-amputation, indicating a significant gap in well-tested, multidimensional measures that can be used for both prosthetic and wheelchair users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Reported Outcome Measures for Major Lower Limb Amputation Caused by Peripheral Artery Disease or Diabetes: A Systematic Review. Miller, R., Ambler, GK., Ramirez, J., et al.[2022]

The newly developed Below Knee Carbon Fibre Shaft Endo-Skeletal (BK ES CF) Prosthesis was provided to 815 amputee patients, with performance feedback collected from 500 of them.

Over 86% of patients reported satisfaction with the prosthesis, indicating it allowed them to achieve an almost normal gait, highlighting its effectiveness in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Appraisal of Indigenous Below Knee Endoskeletal Carbon Fibre Prosthesis. Pithawa, AK., Singh, G., Ravindranath, G.[2020]

In a study of 510 adults aged 18-64 who underwent lower limb amputation, 443 (87%) received a prosthesis within 12 months, with an average time to receipt of 138 days, indicating a relatively timely access to prosthetic devices post-amputation.

Patients with diabetes or vascular disease received their prosthesis 22% faster than those without these conditions, while women experienced delays, receiving their prosthesis at an average of 141 days compared to 106 days for men, highlighting disparities in access based on health status and gender.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors that influence time to prosthesis receipt after lower limb amputation: A Cox proportional hazard model regression. Miller, TA., Paul, R., Forthofer, M., et al.[2023]

In a study of 53 patients who underwent amputation due to peripheral vascular disease, about 75% were able to return to a useful life with the help of modern prosthetic devices or wheelchairs, indicating effective rehabilitation.

While amputation is not the preferred option compared to revascularization, the outcomes show that with current prosthetic technology, patients can achieve a good quality of life post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critical review of amputation in vascular patients. High, RM., McDowell, DE., Savrin, RA.[2022]

A structured protocol for testing lower limb prostheses emphasizes safety, requiring users to meet specific graded safety levels before progressing to more challenging environments.

This approach aims to reduce the risk of falls and injuries, thereby enhancing user confidence and overall experience with active prosthetic legs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a stepwise safety protocol for lower limb prosthetic risk management in a clinical investigation. Thesleff, A., Ahkami, B., Anderson, J., et al.[2022]

In a study of 87 patients who underwent amputation at Ayder Referral Hospital in Ethiopia, the most common causes were trauma (37.7%), tumors (24.1%), and peripheral arterial disease (20.7%), highlighting the need for preventive measures.

The majority of amputations were major lower limb procedures (58.6%), suggesting that improving safety awareness and encouraging early medical intervention could reduce the incidence of these potentially preventable cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns and Causes of Amputation in Ayder Referral Hospital, Mekelle, Ethiopia: A Three-Year Experience. Gebreslassie, B., Gebreselassie, K., Esayas, R.[2022]

The review highlights critical safety issues in the rehabilitation of adults with amputations, focusing on areas such as prosthesis use, fall risks, wound care, and pain management.

Effective communication among the multidisciplinary rehabilitation team and thorough education for patients and caregivers are essential for implementing safety measures and preventing injuries during the rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in the rehabilitation of the adult with an amputation. Latlief, G., Elnitsky, C., Hart-Hughes, S., et al.[2022]

The rising prevalence of amputations has led to a demand for better prosthetic devices, as current options often lack comfort, control, and effective functional restoration, which can lead to long-term health issues like arthritis and pain.

Recent advancements in bionic prosthetics and robotic integration show promise for enhancing rehabilitation and improving the quality of life for individuals with limb loss, alongside innovative surgical techniques being explored for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in bioelectric prostheses. Pasquina, PF., Perry, BN., Miller, ME., et al.[2020]

The Danish Amputation Register (DAR) has been collecting comprehensive data on upper and lower extremity amputations and prosthetic fittings since 1972, with a total of about 5000 voluntary reports during its initial phase (1972-1980).

From 1978-1984, the register transitioned to receiving annual data from the National Patient Register, ensuring complete national coverage of amputations in Denmark, although with less detail than the initial phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Danish Amputation Register 1972-1984. Ebskov, B.[2022]

Advancements in extremity prostheses, such as myoelectric prostheses and osseointegration, are transforming the experience of amputees by providing more intuitive and user-friendly devices.

Techniques like targeted muscle reinnervation not only reduce pain but also significantly enhance the quality of life for individuals who have undergone amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted muscle reinnervation and prosthetic rehabilitation after limb loss. Mioton, LM., Dumanian, GA.[2022]

Current lower limb prostheses lack the ability to replicate the energy distribution and function of natural musculature, which is crucial for effective movement.

The proposed above-knee prosthesis incorporates a self-energized mechanism that captures and stores energy from passive movements at the knee and ankle, enabling active plantar-flexion and improving locomotion efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active plantar-flexion above-knee prosthesis: concept and preliminary design. Rigas, C.[2017]

The new robotic leg prosthesis effectively mimics the biomechanics of a biological leg while matching the weight, size, and battery life of traditional prostheses, making it more practical for daily use.

Preclinical tests with three individuals showed that this prosthesis allows for natural walking movements and includes a passive mode for unlimited walking on level ground without needing to recharge, which is a significant advancement over existing powered prosthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A lightweight robotic leg prosthesis replicating the biomechanics of the knee, ankle, and toe joint. Tran, M., Gabert, L., Hood, S., et al.[2023]

Active prostheses, unlike passive ones, can convert movements from other body parts into actions in the artificial limb, offering greater functionality beyond just cosmetic appearance.

Myoelectrically controlled prostheses use electrical signals from the muscles in the residual limb to control movement, providing a more intuitive and responsive experience for the user.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prosthetic possibilities after amputations in the upper extremities]. Grüttner, B., Frohnauer, G., Burgkart, R.[2022]

Surgeons should consider the biomechanical and design constraints of prostheses when performing amputations to ensure a better fit and function for the patient.

The abstract discusses different types of prostheses and their features, emphasizing the importance of tailoring the amputation stump to accommodate these devices for both lower and upper limb amputations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The stump and the prosthesis. Day, HJ.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Posttraumatic growth in individuals with amputations. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Patient Reported Outcome Measures for Major Lower Limb Amputation Caused by Peripheral Artery Disease or Diabetes: A Systematic Review. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Clinical Appraisal of Indigenous Below Knee Endoskeletal Carbon Fibre Prosthesis. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Factors that influence time to prosthesis receipt after lower limb amputation: A Cox proportional hazard model regression. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A critical review of amputation in vascular patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Design of a stepwise safety protocol for lower limb prosthetic risk management in a clinical investigation. [2022]

7. Ethiopia pubmed.ncbi.nlm.nih.gov

Patterns and Causes of Amputation in Ayder Referral Hospital, Mekelle, Ethiopia: A Three-Year Experience. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Patient safety in the rehabilitation of the adult with an amputation. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Recent advances in bioelectric prostheses. [2020]

10. France pubmed.ncbi.nlm.nih.gov

The Danish Amputation Register 1972-1984. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Targeted muscle reinnervation and prosthetic rehabilitation after limb loss. [2022]

12. France pubmed.ncbi.nlm.nih.gov

Active plantar-flexion above-knee prosthesis: concept and preliminary design. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

A lightweight robotic leg prosthesis replicating the biomechanics of the knee, ankle, and toe joint. [2023]

14. Germany pubmed.ncbi.nlm.nih.gov

[Prosthetic possibilities after amputations in the upper extremities]. [2022]

15. England pubmed.ncbi.nlm.nih.gov

The stump and the prosthesis. [2022]